MAUDE Adverse Event Report: TEOXANE SA RHA 3; HYALURONIC ACID DERMAL FILLER

Lot Number	23042GL1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Foreign Body Embolism (4439)
Date of Event	11/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This event occured outside the usa, in canada.On 04-dec-2023, the canadian distributor notified us of an adverse event.According to the information received, a patient was injected on (b)(6) 2023 with teosyal rha 3 in the nasolabial folds (fanning technique, using a needle).The same day, on (b)(6) 2023, the patient developed pain in the right nasolabial fold.Five days later, on (b)(6) 2023, she returned to the clinic and presented with a vascular occlusion of the angular artery : significant duskiness and skin mottling on the right nasolabial fold region, right lateral nasal wall, radix and right forehead.There was no areas of necrosis, although some scabbing on the right medial cheek.The skin was pink and only slightly mottled and quite tender to touch.There was no dysfunction in any motor nerves.On (b)(6) 2023, the patient received as treatment high dose pulsed hyaluronidase (hdph) protocol (4 doses of hdph each one hour apart, 450 iu / session) and two additional sessions of hyaluronidase (900 ui each) on (b)(6) 2023.She had one session of hyperbaric oxygen therapy (hbot) on 01-dec-2023, but couldn't do more due to claustrophobia.She was also prescribed antibiotic (keflex, 500mg for 7 days).Her skin did improve after this treatment.On (b)(6) 2023, the patient had a second opinion from a doctor.He reported that she was healing well and that all treatments were appropriate and evidence-based.He recommended one session of platelet-rich plasma (prp) to the mottled skin areas to hasten and improve healing.The patient was relieved and consented to the treatment.12 cc of prp were injected with no complication.On (b)(6) 2023, we were informed that the patient had a follow up review and was healed up, especially after the prp.Therefore the complaint was considered closed.
Additional Manufacturer Narrative
Vascular complications are rare and serious side effects, although they are widely known and documented in the context of dermal filler injections.They are related to the accidental injection of the product inside a blood vessel, leading to its occlusion.The local deprivation of blood supply causes tissue anoxia.If enough hyaluronidase is injected on time, symptoms can be fully resolved without sequalae.If the vascular complication is not detected, diagnosed, and treated promptly, it can lead to skin necrosis.The risk of such adverse reactions is mentioned in the instructions for use of teosyal products.

• Brand Name: RHA 3
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, geneva 1203 ; SZ 1203
• Manufacturer Contact: juliette vrangos ; rue de lyon 105; geneva, geneva 1203 ; SZ 1203
• MDR Report Key: 18335076
• Report Number: 3005975625-2023-00892
• Device Sequence Number: 8489277
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 01076401732300451023042GL117250131
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Lot Number: 23042GL1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Female